Essure Litigation

This Week in Mass Torts Around The Country:

By Mark A. York

Xarelto MDL 2592: Are Settlement Talks Coming to Xarelto Litigation?

> During the January 30, 2018 monthly status conference hearing in Xarelto products liability MDL No. 2592, US District Court Judge Eldon Fallon stated that this MDL is nearing its end, and “I need to devise an end game,” as he now seems to be pushing both sides toward a resolution. He also referred to selection of cases to remand where 400 cases each will be selected by plaintiff and defense counsel and 400 more by the court, for a total of 1200 cases being designated for remand back to the court of original jurisdiction for trial or settlement.

Opioid Crisis:

> Insys Therapeutics Sued by New York Attorney General for “Opioid Marketing Abuses” Even After MDL Judge Schedules Settlement Conference Inviting State AG’s

How will Opiate MDL 2805 Judge Polster view NY AG’s suit after he requested states attend his January 31, 2018 full day opioid “settlement” meeting in Cleveland? More than 200 attorneys for city and county governments as well as unions and others met all day in closed door meetings. The day included presentations by non-legal “opioid experts” including Dr. Anna Lembke from Stanford, Dr. Aaron Kesselheim from Harvard Medical School who offered views on the who, how and why the opioid drug makers were able to create the opioid crisis, including how Congress hindered attempts at controlling Big Pharma as well as Joseph Rannazzi, former DEA Head of Diversion Control who spoke to restrictions on DEA enforcement against opioid abuses by drug manufacturers and distributors.

>New York State Attorney General Eric T. Schneiderman on Thursday became the latest attorney general to sue Insys Therapeutics Inc. for allegedly misrepresenting that a spray version of the opioid fentanyl is safe for non-cancer patients and appropriate for mild pain.
Schneiderman alleged in state court that Insys’ marketing of the drug Subsys for unapproved uses caused physicians to overprescribe the treatment, exacerbating the opioid epidemic currently affecting New York and many other states. The MDL judge has stated he wants all parties to come to the settlement table with an open mind, however behind the scenes parties are expressing different views on a quick settlement, since more and more of the suits filed against “Opioid Big Pharma” are RICO claims and some parties want to punish the drug makers for creating the opioid crisis.

>A former Insys Therapeutics Inc employee going to trial for paying kickbacks to doctors to prescribe fentanyl, has requested the court bar U.S. prosecutors from referring to the “opioid crisis” at his trial. Defendant, Jeffrey Pearlman, a former Insys district sales manager , filed a motion asking a Connecticut federal judge to bar references at his trial to the crisis and evidence the dangers opioids pose. His lawyers cited the “rampant media attention” devoted to opioids, stating “jurors would likely have strong biases against someone like Pearlman whose company sold and marketed opioids:, even though Pearlman and Insys engaged in rampant illegal sales and marketing of Subsys, the Insys Theraputics, Inc. fast acting fentanyl based opioid drug. . Pearlamn is jusyt one of more than 15 people at Insys to be indicted, including billionaire founder, John Kapoor, and the entire Board of Directors, for marketing off-label prescriptions of Subsys fentanyl spray (United States of America v. Michael L. Babich, et al., No. 16-cr-10343, D. Mass.).

NEW YORK — The Second Circuit U.S. Court of Appeals on Oct. 24 affirmed the exclusion of general causation experts in the Mirena multidistrict litigation and a court order terminating the MDL before any trials were held (In Re: Mirena IUD Products Liability Litigation, Mirena MDL Plaintiffs v. Bayer HealthCare Pharmaceuticals, Inc., Nos. 16-2890 and 16-3012, 2nd Cir)

“Bayer Facing New Litigation Over Essure Birth Control Device”

By Mark York (November 20, 2017)

Mass Tort Nexus

(MASS TORT NEXUS) On November 2, 2017, fifty-three plaintiffs from Florida, Illinois, Texas and other states across the country have filed a lawsuit over allegations that Bayer’s Essure permanent female birth control device caused serious injuries. This filing is another in a series of ongoing Essure lawsuits against Bayer in different federal and state venues across the country, including the Bayer Essure Litigation USDC Missouri Case No. 4:17-cv-00865.

The primary claims against Bayer, that upon insertion of the device, by insertiing micro-inserts into the fallopian tubes which then anchor and elicit tissue growth, theoretically causing the blockage. However, in reality, the device migrates from the tubes, perforates organs, breaks into pieces and/or corrodes, wreaking havoc on the female body.

Maria Gonzalez, Israel Gonzalez, and the other plaintiffs filed a multi-plaintiff complaint on Nov. 2 in the U.S. District Court for the Eastern District of Pennsylvania against Bayer Healthcare Pharmaceuticals Inc. alleging negligence and other counts under case number 2:17-cv-04936-JP, U.S. District Court for the Eastern District of Pennsylvania. Additionally there are other multi-plaintiff actions against Bayer, where Essure is the product in suit, see California JCCP Complex Litigation Docket consolidated Essure cases pending there, underEssure Product Cases and Actions, JCCP Proceeding No. 4887, Alameda County Superior Court.

According to the most recent federal complaint, the plaintiffs or their partners were implanted with defendant’s Essure device. They allege that the devices “migrated, fractured, punctured internal organs and/or caused other serious injuries.” The company has long been aware of the adverse events and concerns raised over the Essure products, but have yet to admit liability, and have vigorously defended all claims against the company and Essure.

The plaintiffs state that Bayer Healthcare Pharmaceuticals Inc. is responsible because the defendant “manipulated their reports to the FDA and presented false and misleading information, which, in turn, resulted in plaintiffs’ consent to implant not being informed because critical facts regarding the nature and quality of side effects from Essure were concealed from plaintiffs and their physicians,” as cited in the complaint.

The plaintiffs seek past and future general damages, economic and special damages, medical expenses, punitive and exemplary damages, court costs, interest and any further relief the court grants.

These 53 plaintiffs, combined with the other lawsuits filed in various courts across the country now total more than 1500 claims against Bayer, where women have asserted that the company was aware of the damage and healthcare risks of it’s Essure products, and has intentionally disregarded the ever growing evidence that shows the product to be dangerous. If Bayer Healthcare is taking the same position in this new round of claims as in others, plaintiffs will be in for a long and protracted legal fight, with Bayer being an unwilling party to come to the table for any worthwhile discussions. To follow this emerging litigation see Mass Tort Nexus Essure Litigation Case No. 2:17-cv-04936-RBS.

Case Docket: U.S. District Court for the Eastern District of Pennsylvania case number 2:17-cv-04936-JP

XARELTO in Philadelphia Court of Common Pleas: Will The “California Plavix” Supreme Court Ruling Affect Out of State Plaintiffs?

By Mark A. York

Mass Tort Nexus (September 26, 2017)

Bayer, which has a headquarters in Pennsylvania, recently used a June 2017 U.S. Supreme Court decision on out of state plaintiffs and court jurisdictions to dismiss dozens of lawsuits from a Missouri federal court in the “Essure” birth control litigation. It remains to be seen if Bayer will use the same strategy in other jurisdictions, like Philadelphia, where the Xarelto blood thinner cases are piling up, see XARELTO Case No. 2349 in Philadelphia Court of Common Pleas Briefcase.

The many claimants who have brought their lawsuits in Philadelphia will have to see if pharmaceutical companies like Bayer, Johnson & Johnson and others who are facing many thousands of other claims from out-of-state plaintiffs, will rely on the June 19th U.S. Supreme Court ruling that states an out-of-state plaintiff couldn’t file suit in California, due to a lack of jurisdiction.

The Supreme Court justices ruled 8-1 in favor of Bristol Myers-Squibb after the company argued plaintiffs living outside California who alleged injury from BMS’s blood thinner Plavix, should not be able to sue the company in that state.

The Supreme Court ruled that, essentially the “all inclusive view of personal jurisdiction by non-resident plaintiffs has come to an end.” Plavix was not designed or made in California, and the company is headquartered in New York. The ruling may simply force thousands of pending cases across the country to be refiled in other venues, as plaintiff firms are not likely to simply withdraw the cases as massive losses, without having their day in one court or another.

A non-residents plaintiff can file suit in the Philadelphia County Court of Common Pleas, if the defendant is either incorporated in Pennsylvania, or has a principal place of business in Pennsylvania, which limits the legal options for Bayer, based on their corporate headquarters in the state.

Two of the biggest mass tort programs in the Philadelphia Complex Litigation Center docket are the Risperdal litigation, which is produced by Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) and allegedly causes males to develop breasts, Janssen has been hit with several large multi-million dollar verdicts in Risperdal trials. The other is Xarelto, a blood-thinner made by Bayer and Johnson & Johnson that allegedly causes uncontrolled bleeding events, and the makers failed to warn of the dangers. The Xarelto MDL 2592 in US district Court ED Louisiana . see Xarelto MDL 2592 Mass Tort Nexus Briefcase, where close to twenty thousand additional Xarelto cases are pending.

Bayer will be having a much harder time using the BMS Plavix decision to dismiss non-resident plaintiffs from the Philadelphia courtroom, given it’s headquarters in Pittsburgh, Pennsylvania.

“Women are forced to undergo hysterectomies to remove a birth control device, Essure which is manufactured and marketed by Bayer AG, according to the British Medical Review Board”

The Essure birth control implant is used to permanently sterilize women, but is now recognized as a cause of significant side effects and complications also known in the healthcare industry as “adverse events” with the United Kingdom and European Union now restricting use of the permanent birth control device. This action has now started the FDA review in the United States of Essure and the process that Bayer stated showed the device was tested and determined safe.

One woman in Great Britian – who later had her uterus removed – said she was left suicidal due to the “unbearable” pain, and felt she was a burden to her family.

The manufacturer Bayer says Essure is safe and the benefits outweigh the risks, which has been met with speculation as the sale of the implants in the EU was temporarily suspended this month and Bayer has asked hospitals in the UK not to use the device during this time.

“Too painful to move”

Laura Linkson, was alo fitted with the Essure device in 2013, and said the pain left her suicidal.

“The device was sold to me as a simple and easy procedure. I was told that I’d be in and out of the doctor’s office in 10 minutes and that there’d be no recovery time.

“I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal.

The small coil implants, which are made of nickel and polyester (PET) fibres, are used as a sterilization device to stop eggs reaching the womb.

They are inserted into the fallopian tubes where they trigger inflazmation, causing scar tissue to build up and eventually block the tubes, known as a hysteroscopic sterilization.

They can cause intense pain, and some women are thought to react badly to the nickel and plastic.

Because of the way the coils attach to the fallopian tubes, the only way to take them out is to remove a woman’s fallopian tubes and often her uterus.

In other cases the device has been found to perforate fallopian tubes and fallen out, embedding itself elsewhere in the body.

Victoria Dethier was implanted with Essure in 2012 and for three years could not work out why she felt so unwell. “There were moments where I couldn’t get out of bed I was in so much pain. It felt like I was dying, like something was killing me from the inside,” she said.

She thinks her body was reacting to the PET fibres designed to cause inflammation.

She had a hysterectomy to remove the device in 2015. “Straight away there was a difference, I’d experienced a horrible taste in my mouth and that had gone,” she explained.as well as I’d lost a lot of hair and that came back within 12 months, it was incredible.”

“We need acknowledgement by Bayer”

The medicines and healthcare products regulatory agency (MHRA – UK) has been criticized for not responding to the increasing evidence regarding the device.

In 2015, a study published in the British Medical Journal (BMJ) suggested that women who had a hysteroscopic sterilization were 10 times more likely to need follow-up surgery than those who had a traditional sterilization – 2.4% of those surveyed, as opposed to 0.2% amongst those having a standard sterilization.

In the US more than 15,000 women have reported problems to the US Food and Drug Administration (FDA), including pain, allergic reactions and “migration of device” that are involved in thousands of lawsuits versus Bayer Corporation and it’s German parent Bayer, AG.

Carl Heneghan, from the Centre for Evidence-Based Medicine at Oxford University, has criticized the regulator’s failure to act on such findings. “How much evidence do you need to say let’s withdraw this product from the market?” he asked.

Victoria Dethier is angry that she and so many other women feel they have been ignored “No-one is listening to us, and now there are many women coming forward… we need to be acknowledged.”

Bayer Says “No long-term evidence of adverse events”

The full extent of the problem in the UK is not known.

The MHRA rejected the Victoria Derbyshire program’s Freedom of Information request asking how many women have reported problems.

The NHS does not have figures for the total number of women who have been fitted with Essure, or who have had it removed.

However, the clinical trial that led to the device being approved has been criticized for not considering the long-term effects of the implants, which Bayer has defended to this day. “The trial… only followed up women for one year, so nobody has a real understanding of what happens with this device after two years, three years, five years,” Mr Heneghan explained, and based on worldwide reporting of thousands of “adverse Events” it now seems that Bayer will have to begin the process of accepting responsibility for the Essure device medical problems claimed by the thousands of women who had the device implanted.

Some women who have experienced problems say they were not informed about the risks.

But Ben Peyton-Jones, a British consultant-obstetrician and gynecologist, said the device should still be used in some instances. Starting “I think it has a place for women who can’t have keyhole surgery and who are explained the risks very carefully,” when asked about the continued viability of Essure.

“When used correctly, according to the manufacturer’s guidance and in trained hands, it is safe.”

European Union Essure Use Suspended

The sale of Essure implants in the EU has now been suspended for further investigation and hospitals have been asked by Bayer not to use their existing stocks during this time. This is a voluntary request and up to individual trusts to decide what to do.

The company said that independent reviews of Essure had concluded that the benefits outweighed the risks.

“Patient safety and appropriate use of Essure are the greatest priorities for Bayer, and the company fully stands behind Essure as an appropriate choice for women who desire permanent contraception,” it added in a statement. Bayer will immediately start damage control in the USA as soon as the UK-EU restrictions on Essure become known, specifically in the massive Essure Multidistrict Litigation, wher thousands of women in the United States are alleging major complications and onset of medical disability due to the Essure “adverse events” even while Bayer insisted the product was safe.

“Many women with Essure rely on this form of contraception without any side effects.”

The MHRA said it had no evidence to suggest this product was unsafe, and that the recent suspension did not suggest any increased risk to patient safety.

It said it was important for healthcare professionals to discuss the risks with patients before a procedure.

Some 55 actions were consolidated in state court by some 900 women who alleged that they sustained injuries from Essure. The suits contend that the Bayer product, an FDA-approved medical device that has been on the market since 2002, caused a number of problems and physical injuries in thousands of women who have had the device implanted.

As chair of the PEC, Fitzpatrick will lead a five-person Executive Committee, as well as two liaisons, in seeking compensation for alleged harms suffered by the women. The PEC is responsible for coordinating the activities on behalf of all Plaintiffs’ during all pretrial proceedings.

Thousands of women across the U.S. claim Essurehas caused serious and permanent injuries, including hundreds represented by Motley Rice. The FDA reports that more than 9,000 voluntary complaints have been submitted by women allegedly harmed by Essure. While Bayer has denied any wrongdoing, the FDA announced in February 2016 that it will require the company to conduct a clinical study and implement a patient decision checklist to make sure potential users of Essure understand the potential, serious risks implanting the device may cause. Additionally, in October 2016, the FDA added a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.

Reported Essure complications include life-threatening ectopic pregnancy, fetal death, migration of the device causing perforation or tear of pelvic organs, additional surgeries, including hysterectomy to remove the device and repair organs, and other severe side effects.

“We stand firm that our clients and all affected by Essure deserve to have their stories heard,” stated Fitzpatrick. “I welcome the opportunity to represent these women as lead, working closely with fellow members of the Plaintiffs’ Executive Committee, and will do all in my power to achieve justice on their behalf.”

The FDA recommended on Nov. 15 that health care providers thoroughly discuss available sterilization and birth control methods with their patients, including their benefits and risks of Bayer’s Essure permanent birth control system.

Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal.

A California judge ordered that all California product liability lawsuits brought against Bayer Corporation and several subsidiaries involving its Essure birth control device will be coordinated before a single judge in Alameda County Superior Court going forward. The case is Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887.

Sterilization options

The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.

Essure is a permanently implanted birth control device for women (female sterilization). Implantation of Essure does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been examining the growing number of adverse event reports associated with the use of Essure. Reported adverse events include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure failure, and, in some cases, incomplete patient follow-up, have resulted in unintended pregnancies.

A California judge ordered that all California product liability lawsuits brought against Bayer Corporation and several subsidiaries involving its Essure birth control device will be coordinated before a single judge in Alameda County Superior Court going forward.

The Sept. 30 Order Granting the Petition for Coordination will facilitate efficient adjudication in the California court system and coordinate the efforts on behalf of all the women injured by Bayer’ s device. The case is Essure Product Cases and Coordinated Actions, Judicial Council Coordination Proceeding No. 4887.

Prior to Judge Winifred Y. Smith’s order granting the plaintiffs’ petition, there were some 55 actions brought throughout California by some 900 women who alleged that they sustained injuries from Essure. The suits contend that the Bayer product, an FDA-approved medical device that has been on the market since 2002, caused a number of problems and physical injuries in thousands of women who have had the device implanted.

Black box warning

The FDA announced in February 2016 that the device will require a black box warning indicating extreme risks and possible serious injuries associated with its usage, and has instructed Bayer to engage in further post-market study of the device’s safety.

Plaintiffs’ counsel Elizabeth Graham of Grant & Eisenhofer and Fidelma Fitzpatrick of Motley Rice argued for the coordination of all state court actions in the Essure litigation on Sept. 30 before Judge Smith in the Superior Court of California in Alameda County.

Kim Dougherty of Janet, Jenner & Suggs and Erin Copeland of Fibich, Leebron, Copeland, Briggs & Josephson, and Ed Wallace of Wexler Wallace also led in the representing of plaintiffs in the litigation. Also handling the case for Grant & Eisenhofer is Thomas Ayala.

Ms. Graham, who leads Grant & Eisenhofer’s complex pharmaceutical and medical device litigation practice, noted that having the Essure matters before a single judge as coordinated proceedings will greatly assist the thousands of women injured by Essure, enabling them to essentially litigate their claims in one courtroom.

“This is a very favorable development for these injured women. Having these cases coordinated before a single judge will avoid inconsistent rulings and allow these women to prosecute their claims in a cohesive and unified manner,” said Ms. Graham. “Coordinated proceedings in the Essure litigation will enable counsel to fast-track the case, streamline discovery. The JCCP coordination will hopefully bring a swifter judicial remedy to all the women who were injured by Bayer’s Essure procedure.”

Judge Winifred Y. Smith in Superior Court of California, Alameda County, issued a decision on Aug. 2, 2016, permitting the claims of 14 women who believe they were injured by Essure to proceed against the manufacturer, Bayer.

The court found that the claims were not expressly or impliedly preempted under federal or state law.

Ruling improves prospects

Motley Rice attorney Lou Bograd argued the preemption issue on behalf of the Plaintiffs and attorney Fidelma Fitzpatrick also participated in July 29 hearing. While this proceeding directly addressed claims in 11 consolidated cases filed in California State Court by the 14 women, it improves the prospects for recovery of thousands of women alleging they were seriously injured by their use of Essure, including hundreds of women represented by Motley Rice.

Thousands of women across the U.S. claim the permanent birth control device Essure has caused serious and permanent injuries. Essure manufacturer Bayer asserted that the Plaintiffs, and similarly situated women, are barred from bringing claims against it due to federal preemption law. Bayer claims that because Essure is a Class III medical device that was approved by the FDA in 2002, it is immune from lawsuits brought by the victims of the device.

Judge Smith rejected Bayer’s request for immunity, instead finding that the Plaintiffs could proceed with the causes of action related to:

Bayer’s alleged failure to adequately warn the FDA, and thereby the public, of Essure’s potential dangers and adverse side effects.

Claims that Bayer breached Essure’s warranties and misrepresented Essure’s safety and efficacy through advertising and promotional materials that were not approved by the FDA.

Negligently trained physicians

The judge stated that the Plaintiffs’ claims that Bayer negligently trained physicians and manufactured the Essure device improperly could also survive preemption, but that Plaintiffs must replead those claims with more details on how Bayer’s conduct caused the Plaintiffs’ injuries.

“I am extremely encouraged by Judge Smith’s decision,” says Motley Rice Essure lawyer Fidelma Fitzpatrick. “Bayer should not be allowed to hide behind preemption and should be made to answer to each woman injured by Essure.”

In February 2016, the FDA announced it will require Bayer to conduct a clinical study, implement a patient decision checklist to make sure potential users of Essure understand the risks of the product, and add a black box warning to Essure’s labeling. A black box warning is the FDA’s highest warning level and indicates that a product may cause serious injuries or death.

“Bayer, like many other drug and medical device manufacturers, has been trying to use the doctrine of preemption to immunize itself from liability and deny women alleging injury by its product their day in court,” Bograd says. “In the Essure litigation, we are prepared to tackle all legal hurdles Bayer throws at us and to continue working toward allowing our clients to be heard.”

Black box warning

The FDA issued a “black box warning” for the device in February 2016 amid allegations that Bayer concealed the risk associated with Essure. The agency’s warning indicates extreme risks and possibly serious injuries associated with the use of Essure and includes warnings that the device can migrate out of place, cause chronic pelvic pain, and related symptoms.

The plaintiffs’ actions are currently being brought as 11 separate suits in California, along with leading plaintiffs’ class action firm Grant & Eisenhofer, the law firms Janet, Jenner & Suggs, LLC and Motley Rice LLC also represent plaintiffs in the actions.

“We believe that Bayer concealed from patients and the public the magnitude of risk associated with Essure, and that thousands of women suffered needless pain as a result of being deprived of vital information regarding the safety of this product,” said Elizabeth Graham, who leads Grant & Eisenhofer’s complex pharmaceutical and medical device litigation practice, and who is litigating the case alongside G&E’s Thomas Ayala.

A Florida woman who was the first to file a lawsuit against Bayer for negligence and breach of express warranties concerning the Essure birth control device, has led the way for litigation by others who were severely injured by the implanted device.

The lawsuit, filed in Philadelphia Court of Common Pleas, is not a products liability case, but an action for negligence because Bayer did not provide training to the physician on how to insert the device safely.

Doctor with no training

Heather Walsh obtained the Essure implant from a physician who did not receive any training from Bayer on how to insert the device. The device – a coil made of stainless steel, titanium and plastic — is inserted into the fallopian tubes. The coils expand and scar tissue forms around them blocking the fallopian tubes and resulting in sterilization, according to the complaint

Walsh was hospitalized for severe pain and fainting spells two years after getting the implant. A CT scan revealed the device had migrated in her body and lodged behind her colon. Walsh underwent a complete hysterectomy and other surgeries to remove the device from her colon.

Walsh is not alone, as more than 4,000 reports of serious complications from use of the Essure device have been reported to the FDA, including the report of woman who died during surgery to remove the implant in January 2015.

Angie Firmalino received the implant in 2009 and after two years, had it removed because the coils broke and migrated to her uterus. Firmalino required several operations including a hysterectomy. She started a Facebook page to warn other women about the dangers of the device, which now has more than 17,000 followers.

Claims not preempted by Medical Device Act

Although Essure has been in use since the FDA issued a Conditional Premarket Approval (CPMA) in 2002, Walsh brought the first Essure lawsuit against Bayer in 2014. The Medical Device Act (MDA) contains a preemption provision that prevents lawsuits for injuries caused by medical device manufacturers for devices that received pre-market approval from the FDA.

In the complaint Walsh filed, she claims that her negligence and breach of express warranties claims are not preempted by the MDA because the “cause of action has nothing to do with the product itself, but rather [Bayer’s] negligence in” allowing an untrained physician use specific equipment provided by Bayer, that the physician was not qualified to use when he erroneously implanted the device, according to the court documents.

In addition, the complaint asserts that the CPMA issued by the FDA was invalid because Bayer did not comply with the express conditions set by the FDA.

Bayer violated FDA conditions

According to the complaint, the FDA and the Department of Health cited Bayer and invalidated the CPMA for its failure to report results from Essure trial studies, including failure rates. It also “actively conceal[ed] [eight] perforations” resulting from Essure implantations.

Bayer was also required to notify the FDA when it took ownership of Essure from its previous manufacturer, Conceptus. Because of Bayer failing to meet the conditions of the CPMA order, the complaint states that the FDA found that Essure is an “adulterated” product that violates the FDA order if it is marketed or sold.

Product pushed on physicians without training

The complaint also alleges that Bayer was neglectful in its “unreasonably dangerous distribution plan” because it failed to provide training to physicians on the insertion method of the device.

In addition, Bayer provided the untrained physicians with specialized equipment, not approved by the FDA order, required to insert the device, even though the physicians were unqualified to use the specialized equipment. In return for the equipment, the physicians were required to purchase at least two Essure kits per month, according to the complaint.

The case is WALSH v. BAYER CORP., et al case number 2:15 – cv-00384 in the First Judicial Court of Pennsylvania Court of Common Pleas.

This article is reprinted with permission from The National Trial Lawyers.